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Finerenone May Delay AFib Onset in Patients With CKD and Diabetes

— Risk of kidney or CV events reduced regardless of atrial fibrillation or atrial flutter history

MedpageToday

Patients with chronic kidney disease (CKD) and type 2 diabetes were about 30% less likely to develop atrial fibrillation (Afib) with finerenone treatment versus placebo, a researcher reported.

In a prespecified exploratory analysis of the FIDELIO-DKD trial, new-onset Afib or atrial flutter (AF) was reported in 3.2% of patients taking the investigational anti-mineralocorticoid drug and 4.5% of those taking a placebo, for a statistically significant 29% relative risk reduction (P=0.0164), according to Gerasimos Filippatos, MD, of the National and Kapodistrian University of Athens/Attikon University Hospital in Greece.

In addition, the effect of finerenone on primary and key secondary kidney outcomes and cardiovascular (CV) outcomes was not significantly impacted by baseline Afib or AF (P=0.16 and P=0.85 for interaction, respectively), they reported in the.

"Finerenone can lower the risk of development of atrial fibrillation in patients with chronic kidney disease and diabetes and can be used as a therapeutic strategy to delay its onset," said Filippatos at a press conference during the American College of Cardiology virtual meeting. "It can also protect the heart and the kidney from further damage caused by chronic kidney disease and diabetes in these patients with or without pre-existing atrial fibrillation."

In 2020, the investigators that the nonsteroidal selective mineralocorticoid receptor antagonist was associated with an 18% reduction in kidney events and a 14% reduction of CV events versus placebo. Filippatos said the current analysis assessed outcomes among patients with and without a history of Afib or AF, and looked at the risks of patients developing those conditions during the study.

FIDELIO-DKD randomly assigned 5,674 patients with CKD and diabetes to finerenone or placebo. Patients were about age 65 and 69% were men who had been diagnosed with diabetes for an average of 17 years. Eligible patients had a urine albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g, an estimated glomerular filtration rate (eGFR) ≥25 to <75 ml/min/1.73 m2, and received optimized doses of renin-angiotensin system blockade, the authors explained.

Outcomes were tracked for a median of 2.6 years. The primary endpoint was a composite of kidney failure, renal death, or sustained decrease in eGFR ≥40% from baseline. Key secondary outcomes included death by loss of heart function, nonfatal heart attack, nonfatal stroke, or hospitalization for heart failure (HF).

The authors reported that new onset Afib or AF was detected in 82 of 2,593 patients who were assigned to 10-mg or 20-mg finerenone once daily, and in 117 patients of 2,620 who were assigned to placebo, for an incidence per 100 patient-years of 1.20 and 1.72, respectively (HR 0.71, 95% CI 0.53-0.94, P=0.0164).

They explained that has suggested that finerenone may help reduce scarring and thickening of the heart tissue, possibly through its action of blocking mineralocorticoid receptors.

"Preventing or delaying the onset of Afib in patients with CKD and diabetes is "particularly important" as Afib can worsen CKD and diabetes can worsen Afib symptoms," Filippatos explained. "Treatment in these patients can also be challenging because they are prone to developing blood clots and bleeding. Finerenone has the potential to reduce the burden of atrial fibrillation in these patients."

Anne Curtis, MD, of the University at Buffalo in New York, commented that "Any time that you have a situation where you see beneficial effects, other than what was seen in the primary outcome of the trial, it is important to know that."

However, Curtis, who was not involved in the study, pointed out that there was a "small percentage in reduction of atrial fibrillation" in the trial, so "I wouldn't go out and treat patients with this drug with the idea of reducing atrial fibrillation. But this could be an added benefit in certain selected patients."

Trial limitations included the possibility that clinically silent or asymptomatic cases of new-onset Afib or AF may have been missed, according to Filippatos and colleagues.

They also noted that their results were in line with those from the , but differed from those of the trial, while the ongoing will test finerenone in new-onset Afib and AF in HF patients with preserved ejection fraction.

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    Ed Susman is a freelance medical writer based in Fort Pierce, Florida, USA.

Disclosures

FIDELIO-DKD was funded by Bayer. Some co-authors are company employees.

Filippatos disclosed relevant relationships with Bayer, Novartis, Vifor Pharma, Medtronic, Servier, Amgen, and Boehringer Ingelheim.

Curtis disclosed relevant relationships with Abbott, Janssen Pharmaceuticals, Medtronic, Milestone Pharmaceuticals, and Sanofi Aventis.

Primary Source

Journal of the American College of Cardiology

Filippatos G, at al "Finerenone reduces onset of atrial fibrillation in patients with chronic kidney disease and type 2 diabetes" J AM Coll Cardiol 2021; DOI: 10.1016/j.jacc.2021.04.079.